Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)

Sponsor
Genuv Inc.
Study ID
NCT04326283
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the safety, tolerability and efficacy of trametinib (SNR1611) in the treatment of amyotrophic lateral sclerosis.

Key Dates

Start date
Apr 2, 2020
Status verified
May 2023
Primary completion
Apr 28, 2023
Completion
Apr 28, 2023

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Trametinib (0.5 mg)
    One tablet of trametinib 0.5 mg per day
  • Experimental: Trametinib (1 mg)
    Two tablets of trametinib 0.5 mg per day
  • Active Comparator: Riluzole (100 mg)
    One tablet of riluzole 50 mg taken twice per day

Primary Outcome Measure

Safety and tolerability of SNR1611: adverse events [ Time Frame: 24-week (24-week extension and additional 48-week are optional) ]

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